Medical Device Safety Data Management
Medical device safety management is the process of identifying and managing potential risks associated with the use of medical devices. The aim is to ensure that the medical devices are safe for patients and healthcare providers. This process includes a range of activities such as design, manufacturing, packaging, labeling, distribution, and post-market surveillance.
There are several regulations and standards that outline the requirements for medical device safety management. For example, the ISO 14971 standard provides guidance on risk management for medical devices, and the FDA has established regulations for medical devices to ensure their safety and effectiveness.
With over 15+ years experience, our medical writing team has helped several pharma and medical device companies by delivering clinical, non-clinical, regulatory, and post-marketing related medical writing services with the following principles: